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NCT Number: NCT06830187

Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients

The goal of this observational case-control study is to evaluate the relationship between temporal bone computed tomography (CT) findings, bone mineral density (BMD), and audiological parameters in adults diagnosed with otosclerosis. The main questions it aims to answer are:

Is there a correlation between temporal bone CT density values and the severity of hearing loss in otosclerosis? Do bone mineral density and serum vitamin D levels differ between otosclerosis patients and individuals without otosclerosis? Researchers will compare patients diagnosed with otosclerosis to a control group without otosclerosis to determine if CT-based density variations are associated with disease severity and systemic bone metabolism markers.

Participants who have already had a temporal bone CT scan as part of their routine clinical evaluation will undergo:

Bone mineral density (BMD) assessment via dual-energy X-ray absorptiometry (DEXA) Serum vitamin D level measurement Audiological testing, including pure tone audiometry and speech discrimination tests This study aims to improve the diagnostic and prognostic understanding of otosclerosis by integrating imaging, metabolic, and audiological data.

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Key information

Conditions

Otosclerosis of Middle Ear Avitaminosis Bone Density Deficiency Diseases Ear Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Otorhinolaryngologic Diseases Otosclerosis Vitamin D Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University Hospitals

Ankara, 06560, Turkey (Türkiye)

Location status: Recruiting

Location contact

İbrahim Emir Yeşil, MD

CONTACT

[email protected]

+905019103056

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Otosclerosis Group):

  • Adults diagnosed with otosclerosis based on audiological and clinical assessment
  • Patients with available high-resolution CT scans and audiological data
  • Individuals who have undergone stapedectomy or stapedotomy surgery
  • Availability of bone mineral density and serum vitamin D data

Inclusion criteria

(Control Group):

  • Patients without otosclerosis but with temporal CT imaging for other indications
  • No history of conductive or mixed hearing loss
  • Availability of BMD and vitamin D data

Exclusion criteria

  • History of primary metabolic bone diseases (osteoporosis, Paget's disease)
  • Use of medications affecting bone metabolism (bisphosphonates, corticosteroids)
  • History of chronic otitis media or prior ear surgeries
  • Patients who received head and neck radiotherapy

Treatment and study plan

Primary outcomes

  1. Temporal Bone CT Density Measurements

    Time frame: Baseline (Preoperative assessment)

    Measurement of bone density at key anatomical sites including the stapes footplate, oval window, and otic capsule, using Hounsfield Units (HU) from high-resolution temporal bone CT scans.

  2. Pure Tone Audiometry (PTA) Thresholds

    Time frame: Baseline (Preoperative assessment)

    Hearing thresholds will be assessed using pure tone audiometry (PTA) across standard frequencies (500 Hz, 1000 Hz, 2000 Hz, 4000 Hz). The average PTA threshold (in dB HL) will be reported to evaluate the severity of hearing impairment.

  3. Air-Bone Gap (ABG) Measurement

    Time frame: Baseline (Preoperative assessment)

    Air-bone gap (ABG) will be assessed at key frequencies (500 Hz, 1000 Hz, 2000 Hz, 4000 Hz) using pure tone audiometry. The mean ABG value (in dB HL) will be reported to evaluate the degree of conductive hearing loss.

  4. Bone Mineral Density (BMD) Scores

    Time frame: Baseline (Preoperative assessment)

    Measurement of bone mineral density in lumbar spine and femoral neck using Dual-Energy X-ray Absorptiometry (DEXA) to explore systemic bone metabolism in otosclerosis patients.

  5. Serum Vitamin D Levels

    Time frame: Baseline (Preoperative assessment)

    Measurement of 25-hydroxyvitamin D levels in blood samples to assess vitamin D status and its potential correlation with otosclerosis progression.

Secondary outcomes

  1. Correlation Between CT Density and Audiological Parameters

    Time frame: Baseline (Preoperative assessment)

    Analysis of the relationship between preoperative CT bone density values and audiometric findings to determine if CT markers predict hearing loss severity.

  2. Association Between Otosclerosis Severity and BMD/Vitamin D Levels

    Time frame: Baseline (Preoperative assessment)

    Statistical analysis to determine whether systemic bone metabolism markers (BMD, serum vitamin D) correlate with otosclerosis severity, as assessed by CT and audiological tests.

Study contacts

Contact information is provided by the study sponsor or research team.

Gamze Atay, Assos Prof

CONTACT

[email protected]

+90 312 305 4224

İbrahim Emir Yeşil, MD

CONTACT

[email protected]

+905019103056

Sponsors and collaborators

Lead sponsor

İbrahim Emir Yeşil

Other

Registry information

Official study title

Radiological and Audiological Correlation in Otosclerosis: a Prospective Case-Control Study Evaluating Temporal Bone CT, Bone Mineral Density, and Hearing Loss

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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